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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER CATHETER, PERIPHERAL, ATHERECTOMY

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THE SPECTRANETICS CORPORATION SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number 417-152
Device Problem Crack (1135)
Patient Problems Unintended Radiation Exposure (4565); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/13/2021
Event Type  malfunction  
Manufacturer Narrative
Patient information unavailable. The component code and health effect impact code (heic) field was intentionally left blank. A supplemental mdr to follow upon availability to enter component code after completion of device evaluation and heic code. The manufacturer is anticipating the return of the device for evaluation, but has not received it at this time.
 
Event Description
A peripheral atherectomy procedure commenced to provide treatment to the patient's superficial femoral artery(sfa). The physician chose to use a spectranetics turbo elite laser atherectomy catheter to treat the patient. During use within the patient, red light was seen emitting from the side of the catheter. It was reported there was a crack in the catheter; however, the physician was unsure of the efficacy of the device. The turbo elite device was reportedly used to complete the procedure with no reported patient harm. This event is being reported due to the potential for exposure to manufacturing materials as well as inadvertent exposure to laser energy/radiation. The manufacturer is anticipating return of the turbo elite catheter for evaluation, but has not received it at this time.
 
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Brand NameSPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER
Type of DeviceCATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
THE SPECTRANETICS CORPORATION
9965 federal drive
colorado springs CO 80921
Manufacturer Contact
9965 federal drive
colorado springs, CO 80921
719447-246
MDR Report Key11807072
MDR Text Key265176845
Report Number1721279-2021-00085
Device Sequence Number1
Product Code MCW
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K170059
Number of Events Reported123
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number417-152
Device Catalogue Number417-152
Device Lot NumberFAZ21B24A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/24/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/03/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/24/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/11/2021 Patient Sequence Number: 1
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